QA Document Control Supervisor (2nd shift)

Job description

Job Description

PLEASE NOTE: This 2nd shift schedule is a 4 day x 10 hour work week (Wednesday - Saturday or Sunday - Wednesday) from 1 PM to 11 PM or 2 PM to 12 AM.

PURPOSE
Supervise QA Document Control team responsible for two-shift operational execution of batch record and label issuance/control and documentation/records lifecycle management in compliance with cGMP legal and regulatory requirements, the Novartis Pharmaceuticals Corporate Quality Manual and Policies, and site procedures and business requirements.

MAJOR RESPONSIBILITIES
• Second shift covering evenings and one or both weekend days as required to support operations.
• Supervise QA Document Control personnel responsible for two-shift operational execution of batch record and label issuance/control and documentation/records lifecycle management activities such as creating, issuing, receiving, reconciling, filing, archiving, and providing execution copies in a compliant and secure manner per cGMP regulatory requirements and in accordance with Novartis procedures and Quality Manual.
• Manage the Documentation and Records Centre and Batch Record and Label Issuance Centre to ensure compliance to business procedures and processes and provide direct operational input/support to critical production path over two-shift operation.
• Print and issue batch records, apheresis labels, batch record/sample labels, and final product labels to support operations.
• Enter/maintain information accurately following GDocP, data integrity, and information security requirements to support operations and overall lifecycle of documents and records.
• Oversee off-site records storage in coordination with Novartis Record Management requirements.
• Oversee contingency process and the issuance of manual documentation. Maintain document master and document contingency lists to ensure they are current.
• Lead/support continuous improvement initiatives, creation and revision of procedures, and development of metrics for Document Control.
• Lead/support deviations, investigations and CAPA creations/execution for Quality Compliance.

SUPPORTIVE RESPONSIBILITIES:
• Implement and ensure adherence of appropriate regulations, quality standards, and global operating procedures.
• Ensure document management, batch record and label issuance/control SOPs reflect current operations and at a minimum are updated to meet the SOP periodic review requirements
• Support validation/qualification activities as needed (e.g. labeling associated with Cell Chain).
• Present documentation quality systems and provide documentation control support for self-inspections, internal/external audits and Health Authority inspections. Interact with FDA, partner and supplier auditors/inspectors as needed.
• Support regulatory filings as needed.
• Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements.
• Perform or support any other tasks necessary to maintain the product quality and site cGMP compliance, as needed.

Posting Title

QA Document Control Supervisor (2nd shift)

Desired profile

Minimum requirements

Education: BA/BS in Biological Sciences, chemistry, pharmacy, engineering or equivalent education/experience in Pharmaceuticals.

Languages: Fluent in speaking / writing in English

Experience: 6 or more years of professional pharmaceutical experience with two or more years of quality assurance and/or compliance experience preferred. Two or more years in a leadership/supervisory role preferred.
Job Type

Full Time
Country

USA
Work Location

Morris Plains
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO BTDM
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.